JP2024528005A - Electric field visualization for electroporation catheters with multiple states - Google Patents

Abstract

A system for electroporation ablation including an electrode assembly and a catheter having one or more states. The electrode assembly may be of different shapes when the catheter is in the different states. The controller is configured to generate a graphical representation of an electric field generated by the electrode assembly when the catheter is in the different states based on one or more models of the electric field. In some embodiments, the controller is configured to overlay the graphical representation of the one or more electric fields on an anatomical map of the patient.

Description

The present disclosure relates to medical systems and methods for ablating tissue in a patient. More specifically, the present disclosure relates to medical systems and methods for ablation of tissue by electroporation.

Ablation procedures are used to treat many different conditions in patients. Ablation can be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Typically, ablation is accomplished by thermal ablation techniques, including radiofrequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into the patient and radiofrequency waves are transmitted through the probe to the surrounding tissue. The radiofrequency waves generate heat, which destroys the surrounding tissue and cauterizes blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient and a cold, thermally conductive fluid is circulated through the probe to freeze and kill the surrounding tissue. RF ablation and cryoablation techniques indiscriminately kill tissue through cell necrosis, which can damage or kill otherwise healthy tissue, such as tissue in the esophagus, phrenic nerve cells, and tissue in the coronary arteries.

Another ablation technique uses electroporation. In electroporation or electropermeabilization, an electric field is applied to cells to increase the permeability of the cell membrane. Electroporation can be reversible or irreversible, depending on the strength of the electric field. If electroporation is reversible, the increased permeability of the cell membrane can be used to introduce chemicals, drugs, and/or deoxyribonucleic acid (DNA) into the cells before they heal and recover. If electroporation is irreversible, the affected cells die by apoptosis.

Irreversible electroporation may be used as a non-thermal ablation technique. In irreversible electroporation, a series of short high voltage pulses are used to generate an electric field strong enough to kill cells by apoptosis. In cardiac tissue ablation, irreversible electroporation may be a safe and effective alternative to the indiscriminate killing by thermal ablation techniques such as RF ablation and cryoablation. Irreversible electroporation may be used to kill targeted tissues such as myocardial tissue by using an electric field strength and duration that kills the targeted tissue but does not permanently damage other cells or tissues such as non-targeted myocardial tissue, red blood cells, vascular smooth muscle tissue, endothelial tissue, and neuronal cells. Planning an irreversible electroporation ablation procedure may be difficult due to the lack of acute visualization or data indicating which tissues have been irreversibly electroporated as opposed to reversibly electroporated. Tissue recovery may occur over minutes, hours, or days after ablation is complete.

In Example 1, a system for electroporation ablation includes a catheter including an electrode assembly and a plurality of states, the electrode assembly having a first shape when the catheter is in a first one of the plurality of states, and the electrode assembly having a second shape when the catheter is in a second one of the plurality of states. The second shape may be different from the first shape, and the electrode assembly may include a plurality of electrodes. The system for electroporation ablation further includes a controller configured to generate a first graphical representation of a first electric field generated by the plurality of electrodes when the catheter is in the first state and deployed proximate to the target location based on a first model of the electric field. The controller may further be configured to generate a second graphical representation of a second electric field generated by the plurality of electrodes when the catheter is in the second state and deployed proximate to the target location based on a second model of the electric field, and overlay the first graphical representation of the first electric field and the second graphical representation of the second electric field on an anatomical map of the patient proximate to the target location in a graphical user interface.

In Example 2, in the system of Example 1, the second shape is dissimilar to the first shape.
In Example 3, in the system of Example 1, the second shape has a smaller volume than the first shape.
In Example 4, the system of any of Examples 1-3, wherein the catheter includes a catheter shaft defining a longitudinal axis, the electrode assembly includes a plurality of splines, a proximal end, and a distal end, at least a portion of the plurality of electrodes disposed on the plurality of splines, and the proximal end of the electrode assembly extends from the catheter shaft.

In Example 5, in the system of Example 4, each spline of the plurality of splines is arranged in a curve around the longitudinal axis between the distal end and the proximal end of the electrode assembly when the catheter is in the first state.

In Example 6, the system of Example 4, wherein the plurality of splines are arranged in a petal-like curve when the catheter is in the second state.
In Example 7, the system of any of Examples 1-6, wherein the controller is further configured to generate an indication of a difference between the first graphical representation of the first electric field and the second graphical representation of the second electric field.

In Example 8, in any of the systems of Examples 1-7, the first graphical representation of the first electric field includes one or more first areas, and an electric field strength of the first electric field in the one or more first areas has a magnitude greater than a predetermined threshold.

In Example 9, in the system of Example 8, the second graphical representation of the second electric field includes one or more second areas, and a magnitude of the electric field strength of the second electric field in the one or more second areas is greater than a predetermined threshold.

In Example 10, the system of any of Examples 1-9, wherein the first graphical representation includes a first representation of a catheter.
In Example 11, in the system of any of Examples 1-10, the controller is further configured to generate a software widget including a second representation of the catheter and an indication of one or more treatment sessions of electroporation ablation performed by the catheter, and present the software widget on the graphical user interface. In some examples, the software widget includes an indication identifying a treatment session of the one or more treatment sessions.

In Example 12, a method for planning electroporation ablation includes generating, by the controller and based on a first model of the electric field, a first graphical representation of a first electric field generated using electrodes on a catheter in a first state, the catheter including an electrode assembly having a first shape when the catheter is in the first state; presenting on a display the first graphical representation of the electric field and an anatomical map of the patient proximate to the target location; generating, by the controller and based on a second model of the electric field, a second graphical representation of a second electric field generated using electrodes on the catheter in a second state, the catheter including an electrode assembly having a second shape when the catheter is in the second state, the second shape being different from the first shape; and presenting on the display the second graphical representation of the electric field and the anatomical map proximate to the target location.

In Example 13, the method of Example 12, wherein the second shape is dissimilar to the first shape.
In Example 14, the method of either of Examples 12 or 13 further includes generating an indication of a difference between the first graphical representation of the first electric field and the second graphical representation of the second electric field.

In Example 15, the method of any of Examples 12-14 further includes generating a software widget including a second representation of the catheter and a display of one or more treatment sessions of electroporation ablation performed by the catheter, and presenting the software widget on a display.

In example 16, a system for electroporation ablation includes a catheter having a plurality of electrodes and a controller configured to generate a software widget including a representation of the catheter and an indication of one or more treatment sessions of electroporation ablation performed by the catheter and present the software widget in a graphical user interface. In some examples, the software widget includes an indication identifying a treatment session of the one or more treatment sessions.

In Example 17, in the system of Example 16, the controller is further configured to generate a graphical representation of the electric field of the plurality of electrodes based on the model of the electric field, and to display the graphical representation of the electric field of the plurality of electrodes.

In Example 18, the system of either Example 16 or 17, the software widget includes a cross-sectional view of the catheter.
In Example 19, the system of any of Examples 16-18, the software widget includes an alignment indicator representing an axial relationship between a catheter axis of the catheter and a target axis of a targeted ablation area of the electroporation ablation.

In Example 20, in the system of any of Examples 16-19, the representation of the catheter includes a first representation of the catheter at a first time and a second representation of the catheter at a second time.

In Example 21, in the system of Example 20, the first representation and the second representation indicate differences between the catheter at the first time and the catheter at the second time, the differences including at least one of a difference in shape, a difference in rotation angle, a difference in electric field strength, and a difference in location.

In Example 22, the system of any of Examples 16-21, the software widget further includes an electric field display representing an electric field generated by the plurality of electrodes.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

FIG. 1 illustrates an exemplary clinical setup for treating a patient using an electrophysiology system and for treating the patient's heart, in accordance with an embodiment of the presently disclosed subject matter. 1 is a schematic diagram illustrating a catheter that can be used for electroporation, including ablation by irreversible electroporation, in accordance with an embodiment of the presently disclosed subject matter. FIG. 1 is a schematic diagram illustrating a catheter that can be used for electroporation, including ablation by irreversible electroporation, in accordance with an embodiment of the presently disclosed subject matter. 1 is a schematic diagram illustrating a catheter that can be used for electroporation, including ablation by irreversible electroporation, in accordance with an embodiment of the presently disclosed subject matter. 1 is a schematic diagram illustrating a catheter that can be used for electroporation, including ablation by irreversible electroporation, in accordance with an embodiment of the presently disclosed subject matter. FIG. 1 is a schematic diagram illustrating a catheter that can be used for electroporation, including ablation by irreversible electroporation, in accordance with an embodiment of the presently disclosed subject matter. 1A-1C illustrate examples of graphical user interfaces according to embodiments of the disclosed subject matter. 1A-1C illustrate examples of graphical user interfaces according to embodiments of the disclosed subject matter. 1 illustrates a software widget that facilitates planning and/or performing an ablation treatment, according to an embodiment of the presently disclosed subject matter. 1 illustrates a software widget that facilitates planning and/or performing an ablation treatment, according to an embodiment of the presently disclosed subject matter. 1 illustrates a software widget that facilitates planning and/or performing an ablation treatment, according to an embodiment of the presently disclosed subject matter. 1A-1C illustrate graphical representations of software widgets and electric fields displayed side-by-side, according to an embodiment of the disclosed subject matter. 1A-1C illustrate graphical representations of software widgets and electric fields displayed side-by-side, according to an embodiment of the disclosed subject matter. 3 shows examples of electric fields with different strengths generated by a catheter including an electrode assembly. 3 shows examples of electric fields with different strengths generated by a catheter including an electrode assembly. FIG. 1 is a flow chart diagram illustrating a method for planning ablation by irreversible electroporation, according to an embodiment of the presently disclosed subject matter.

While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

The following detailed description is exemplary in nature and is in no way intended to limit the scope, applicability, or configuration of the present invention. Rather, the following description provides some practical illustrations for implementing exemplary embodiments of the present invention. Examples of configurations, materials, and/or dimensions are provided for selected elements. Those skilled in the art will recognize that many of the examples mentioned have a variety of suitable alternatives.

As used herein with respect to measurements (e.g., dimensions, characteristics, attributes, components, etc.) and ranges thereof of tangible (e.g., products, inventory, etc.) and/or intangible (e.g., data, electronic representations of currency, accounts, information, parts of things (e.g., percentages, fractions), calculations, data models, dynamic system models, algorithms, parameters, etc.) things, "about" and "approximately" include the referenced measurement and are reasonably close to the referenced measurement, but may vary slightly due to measurement error, differences in measuring and/or manufacturing equipment calibration, human error in reading and/or setting measurements, other measurements (e.g., may be used interchangeably to refer to measurements, including any measurements that may differ by reasonably small amounts as understood and readily ascertained by those skilled in the art due to adjustments made to optimize performance and/or structural parameters taking into account other measurements (e.g., measurements relative to one another), imprecise adjustment and/or manipulation of objects, settings, and/or measurements by humans, computing devices, and/or machines in a particular implementation scenario, system tolerances, control loops, machine learning, predictable variations (e.g., statistically insignificant variations, chaotic variations, system and/or model instability, etc.), preferences, etc.

Although an example method may be represented by one or more drawings (e.g., flow diagrams, communication flows, etc.), the drawings should not be construed as implying any requirement of, or a particular order between, the various steps disclosed herein. However, certain embodiments may require certain steps and/or a particular order between certain steps, as may be explicitly described herein and/or as may be understood from the nature of the steps themselves (e.g., the performance of some steps may depend on the results of previous steps). In addition, a "set," "subset," or "group" of items (e.g., inputs, algorithms, data values, etc.) may include one or more items, and similarly, a subset or subgroup of items may include one or more items. "Plurality" means more than one.

As used herein, the term "based on" is not meant to be limiting, but rather indicates that a determination, identification, prediction, calculation, etc. is made by using at least the term following "based on" as an input. For example, predicting an outcome based on particular information may additionally or alternatively base the same determination on other information.

Irreversible electroporation (IRE) uses short (e.g., 100 microseconds or less) pulses of high voltage to kill cells by apoptosis. IRE can be targeted to kill myocardium and spare other adjacent tissues, including esophageal vascular smooth muscle and endothelium. IRE therapy may be delivered in multiple treatment sections. A treatment section (e.g., 10 milliseconds in duration) may include multiple electrical pulses (e.g., 20 pulses, 30 pulses, etc.) generated and delivered by an electroporation device powered by an electroporation generator.

1 illustrates an exemplary clinical set-up 10 for treating a patient 20 using an electrophysiology system 50 and for treating a heart 30 of the patient 20, according to an embodiment of the subject matter of the present disclosure. The electrophysiology system 50 includes an electroporation device 60, a display 92, and an optional localization field generator 80. The clinical set-up 10 also includes additional equipment, such as an imaging device 94 (represented by a C-arm), and various controller elements configured to allow an operator to control various aspects of the electrophysiology system 50. As will be appreciated by those skilled in the art, the clinical set-up 10 may have other components and arrangements of components not shown in FIG. 1.

The electroporation device 60 includes an electroporation catheter 105, an introducer sheath 110, a controller 90, and an electroporation generator 130. In an embodiment, the electroporation device 60 is configured to deliver electric field energy to a target tissue in the patient's heart 30 to cause tissue apoptosis and render the tissue unable to conduct electrical signals. As described in more detail below, the electroporation device 60 is also configured to generate a graphical representation of an electric field that can be generated using the electroporation catheter 105 based on a model of the electric field, and to overlay the graphical representation of the electric field on an anatomical map of the patient's heart on the display 92 to assist a user in planning an ablation by irreversible electroporation using the electroporation catheter 105 (e.g., planning the ablation before and during the ablation procedure).

In an embodiment, the electroporation device 60 is configured to generate a graphical representation of the electric field based on the characteristics of the electroporation catheter 105 and the position of the electroporation catheter 105 within the patient 20, such as within the heart 30 of the patient 20. In an embodiment, the electroporation device 60 is configured to generate a graphical representation of the electric field based on the characteristics of the electroporation catheter 105 and the position of the electroporation catheter 105 within the patient 20, such as within the heart 30 of the patient 20, and the characteristics of the surroundings of the catheter 105, such as the measured impedance of the tissue.

The controller 90 is configured to control the functional aspects of the electroporation device 60. In an embodiment, the controller 90 is configured to control the electroporation generator 130 to generate electrical pulses, e.g., electrical pulse magnitude, electrical pulse timing and duration. In an embodiment, the electroporation generator 130 is operable as a pulse generator to generate and deliver a pulse sequence to the electroporation catheter 105.

In an embodiment, the introducer sheath 110 is operable to provide a delivery conduit through which the electroporation catheter 105 may be deployed to a particular target site within the patient's heart 30. However, it will be understood that the introducer sheath 110 is illustrated and described herein to provide an overall context of the electrophysiology system 50.

As will be appreciated by one of ordinary skill in the art, the depiction of electrophysiology system 50 shown in FIG. 1 is intended to provide a general overview of the various components of system 50 and is in no way intended to suggest that the present disclosure is limited to any set of components or arrangement of components. For example, one of ordinary skill in the art will readily recognize that additional hardware components, e.g., breakout boxes, workstations, etc., may and likely will be included in electrophysiology system 50.

In the illustrated embodiment, the electroporation catheter 105 includes a handle 105a, a shaft 105b, and an electrode assembly 150. The handle 105a is configured to be manipulated by a user to position the electrode assembly 150 at a desired anatomical location. The shaft 105b has a distal end 105c and generally defines a longitudinal axis of the electroporation catheter 105. As shown, the electrode assembly 150 is located at or near the distal end 105c of the shaft 105b. In an embodiment, the electrode assembly 150 is electrically coupled to the electroporation generator 130 to receive an electrical pulse sequence or train, thereby selectively generating an electric field for ablating the target tissue by irreversible electroporation.

In an embodiment, as shown in FIG. 1, the electrode assembly 150 includes one or more electrodes 152. The electrodes 152 may include ablation electrodes and, optionally, mapping electrodes. In some configurations, the mapping electrodes are configured to be used to generate and display by the display 92 a detailed three-dimensional geometrical anatomical map or representation of the heart chambers, as well as an electroanatomical map in which cardiac electrical activity of interest is superimposed on the geometrical anatomical map.

In certain embodiments, the electroporation catheter 105 is a catheter having an electrode assembly and a plurality of states. In embodiments, the electrode assembly has a first shape when the catheter 105 is in a first of the plurality of states and a second shape when the catheter 105 is in a second of the plurality of states. The electrode assembly includes a plurality of electrodes. In some embodiments, the second shape of the electrode assembly is different from the first shape. In some embodiments, the second shape of the electrode assembly is dissimilar to the first shape. In some embodiments, the volume of the second shape of the electrode assembly is smaller than the volume of the first shape. The catheter 105 may have more than two states. In some embodiments, the catheter 105 has states that are continuous with respect to one another, as opposed to states that are discrete with respect to one another. In other words, the catheter can be tuned along a continuous spectrum of states and is not limited to a discrete finite number of states. In certain instances, the electrode assembly of the catheter 105 may have more than two different shapes.

In some embodiments, the controller 90 is configured to generate a graphical user interface 95 that is rendered on the display 92. In some embodiments, the controller 90 is configured to collect and store data associated with the catheter 105 and/or the treatment session in a data repository (e.g., a file, a database, etc.). In some examples, the controller 90 is configured to generate a first graphical representation of a first electric field generated by the plurality of electrodes based on a first model of the electric field, and a second graphical representation of a second electric field generated by the plurality of electrodes based on a second model of the electric field, and to overlay the first and second graphical representations of the electric fields on an anatomical map of the patient at the location of the catheter on the graphical user interface rendered on the display 92. The first graphical representation is generated when the catheter is in a first state and deployed proximate to the target location. The second graphical representation is generated when the catheter is in a second state and deployed proximate to the target location.

In some examples, the controller 90 is configured to determine the electric field based on known geometries of the electrode assembly of the catheter 105 in different states (e.g., two or more states, a continuum) and generate a corresponding graphical representation of the electric field. In one particular example, the controller 90 is configured to determine the electric field based on known relative electrode locations of the electrode assembly of the catheter 105 in different states (e.g., two or more states, a continuum) and generate a corresponding graphical representation of the electric field.

In some embodiments, the controller 90 is further configured to generate an indication of a difference between the first graphical representation of the first electric field and the second graphical representation of the second electric field. In some examples, the first graphical representation of the first electric field includes one or more first areas, and a magnitude of the electric field strength of the first electric field in the one or more first areas is greater than a predetermined threshold. In some examples, the second graphical representation of the second electric field includes one or more second areas, and a magnitude of the electric field strength of the second electric field in the one or more second areas is greater than a predetermined threshold. In some embodiments, the first graphical representation includes a representation of the catheter 105.

In some embodiments, as described in more detail below, the controller 90 may be configured to generate a software widget including a representation of the catheter 105 and an indication of one or more treatment sessions of electroporation ablation performed by the catheter 105 and present the software widget in a graphical user interface. In an embodiment, the software widget includes an indication identifying a treatment session of the one or more treatment sessions. In an embodiment, the software widget includes a representation of multiple treatment sessions in which the catheter 105 is in various states having various rotational angles, various locations, and/or different shapes (e.g., basket shape, flower shape, etc.). In one example, for an ablation treatment, the catheter is deployed to perform eight treatment sessions, including being positioned at four different rotational angles and positioned in two different shapes at each angle. In some embodiments, the software widget includes a cross-sectional schematic of the catheter 105. The controller 90 may be further configured to generate a graphical representation of the electric field of the multiple electrodes based on a model of the electric field and display the graphical representation of the electric field of the multiple electrodes in the software widget.

In some examples, the representation of the catheter 105 includes a first representation of the catheter at a first time and a second representation of the catheter at a second time. The first and second representations may indicate differences between the catheter at the first time and the catheter at the second time. The indicated differences include at least one of a difference in shape, a difference in rotation angle, a difference in electric field strength, and a difference in location. In some embodiments, the software widget includes an electric field display representing the electric field.

In some embodiments, the software widget includes an alignment indicator that represents alignment information for the catheter 105. In some examples, the alignment indicator represents an axial relationship between the catheter 105 at a first time and the catheter 105 at a second time, e.g., a change in the orientation of the catheter 105 during one treatment session from a previous treatment session. In one particular example, the alignment indicator represents an axial relationship between the catheter and a targeted ablation area of an electroporation ablation treatment.

In some embodiments, one or more mapping electrodes on the electroporation catheter 105 can measure electrical signals and generate output signals that can be processed by the controller 90 to generate an electroanatomical map, also referred to as an anatomical map. In some examples, the electroanatomical map is generated prior to ablation to determine the electrical activity of the cardiac tissue within the cardiac chamber of interest. In some examples, the electroanatomical map is generated after ablation upon verifying desired changes in the electrical activity of the ablated tissue and the cardiac chamber as a whole. The mapping electrodes may also be used to determine the position of the catheter 105 in three-dimensional space within the body. For example, as the operator moves the distal end of the catheter 105 within the cardiac chamber of interest, the boundaries of the catheter movement may be used by the controller 90, which may include or be coupled to a mapping and navigation system to form an anatomical map of the cardiac chamber. The anatomical map of the cardiac chambers can be used to facilitate navigation of the catheter 105 without the use of ionizing radiation, such as fluoroscopy, and to tag the location of the ablation when it is completed to guide the ablation interval and help the operator completely ablate the anatomical structure of interest.

According to embodiments, various components of the electrophysiological system 50 (e.g., the controller 90) may be implemented on one or more computing devices. The computing devices may include any type of computing device suitable for implementing embodiments of the present disclosure. Examples of computing devices include dedicated or general-purpose computing devices such as workstations, servers, laptops, portable devices, desktops, tablet computers, handheld devices, general purpose graphics processing units (GPGPUs), and the like, all of which are contemplated within the scope of FIG. 1 with respect to the various components of the system 50.

In some embodiments, a computing device includes a bus that directly and/or indirectly couples the following devices: a processor, memory, input/output (I/O) ports, I/O components, and a power source. Any number of additional components, different components, and/or combinations of components may also be included in the computing device. Bus represents what may be one or more buses (e.g., an address bus, a data bus, or combinations thereof, etc.). Similarly, in some embodiments, a computing device may include several processors, several memory components, several I/O ports, several I/O components, and/or several power sources. Additionally, any number of these components or combinations thereof may be distributed and/or replicated across several computing devices.

In some embodiments, the system 50 includes one or more memories (not shown). The one or more memories include computer readable media in the form of volatile and/or non-volatile memory, temporary and/or non-transient storage media, and may be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM), read only memory (ROM), electronically erasable programmable read only memory (EEPROM), flash memory, optical or holographic media, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, data transmission, and/or any other medium that can be used to store information and that can be accessed by a computer device, such as, for example, a quantum state memory. In some embodiments, the one or more memories store computer executable instructions for causing a processor (e.g., controller 90) to implement aspects of embodiments of the system components discussed herein and/or perform aspects of embodiments of the methods and procedures discussed herein.

The computer-executable instructions may include, for example, computer code, machine-usable instructions, etc., such as program components that can be executed by one or more processors associated with a computing device. The program components may be programmed using any number of different programming environments, including various languages, development kits, frameworks, etc. Some or all of the functionality contemplated herein may additionally or alternatively be implemented in hardware and/or firmware.

In some embodiments, the memory may include a data repository that may be implemented using any one of the configurations described below. The data repository may include random access memory, flat files, XML files, and/or one or more database management systems (DBMS) running on one or more database servers or data centers. The database management systems may be relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object-oriented (ODBMS or OODBMS) or object-relational (ORDBMS) database management systems, etc. The data repository may be, for example, a single relational database. In some cases, the data repository may include multiple databases that may exchange and aggregate data by a data integration process or software application. In an exemplary embodiment, at least a portion of the data repository may be hosted in a cloud data center. In some cases, the data repository may be hosted on a single computer, server, storage device, cloud server, etc. In some other cases, the data repository may be hosted on a series of networked computers, servers, or devices. In some cases, the data repository may be hosted on tiers of data storage devices including local, regional, and central.

The various components of the system 50 may communicate or be coupled via communication interfaces, e.g., wired or wireless interfaces. The communication interfaces include, but are not limited to, any wired or wireless short-range and long-range communication interfaces. The wired interfaces may use cables, umbilicals, and the like. The short-range communication interfaces may be, for example, local area networks (LANs), or interfaces that comply with known communication standards, such as the Bluetooth standard, the IEEE 802 standard (e.g., IEEE 802.11), ZigBee or similar specifications, such as those based on the IEEE 802.15.4 standard, or other public or proprietary wireless protocols. The long-range communication interfaces may be, for example, wide area networks (WANs), cellular network interfaces, satellite communication interfaces, and the like. The communication interfaces may be in a private computer network, such as an intranet, or on a public computer network, such as the Internet.

2A-2B are schematic diagrams illustrating an electroporation ablation catheter 200 that can be used for electroporation ablation, including ablation by irreversible electroporation, according to an embodiment of the subject matter of the present disclosure. FIG. 2A illustrates the catheter 200 in a first state, and FIG. 2B illustrates the catheter 200 in a second state. The catheter 200 may have two or more states, which may be configurable or controllable by a user, or may be automatically configured by an electroporation system during treatment. The catheter 200 includes a catheter shaft 202 and a plurality of catheter splines 204 coupled to the catheter shaft 202 at a distal end 206 of the catheter shaft 202. The catheter 200 may further include an inner shaft 203 disposed within the catheter shaft 202 and extending distally from the distal end 206 of the catheter shaft 202. As will be appreciated, the catheter shaft 202 is coupled at its proximal end to a handle assembly (not shown) configured to be manipulated by a user during an electroporation ablation procedure. As further shown, the catheter 200 includes an electrode assembly 220 at a distal end that extends from the distal end 206 of the catheter shaft 202.

In an embodiment, the electrode assembly 220 includes a plurality of energy delivery electrodes 225, and the electrode assembly 220 is configured to be selectively operable in a first state and a second state. In some cases, in the first state, the electrode assembly 220 is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter.

In some embodiments, the electrode assembly 220 includes an inner shaft 203 that extends from and is adapted to retract into the catheter shaft 202. In some cases, the electrode assembly 220 includes a plurality of splines 204 coupled to the inner shaft 203 at a distal end 211 of the inner shaft 203. In some cases, the electrode assembly 220 further includes a central shaft 203a having a proximal end 211a (overlapping the distal end 211 of the inner shaft 203) and a distal end 212. In some cases, the plurality of splines 204 are coupled to the distal end 212 of the central shaft 203a. In some embodiments, the electrodes 225 include a plurality of first electrodes 208 and a plurality of second electrodes 210 disposed on the plurality of splines 204. In one example, the plurality of second electrodes 210 are disposed near the distal end 212 of the central shaft 203a, and the plurality of first electrodes 208 are disposed near the proximal end 211a of the central shaft 203a.

Optionally, when operating in the first state, the inner shaft 203 and the central shaft 203a extend from the catheter shaft 202, for example, as illustrated in FIG. 2A. Optionally, in the first state, both the plurality of first electrodes 208 and the plurality of second electrodes 210 are selectively energized and activated to form a relatively large diameter circumferential ablation lesion, for example, as used in a pulmonary vein isolation (PVI) procedure.

In some embodiments, when operating in the second state, the inner shaft 203 and the central shaft 203a are at least partially retracted into the catheter shaft 202 such that all or a portion of the plurality of first electrodes 208 are retracted into the catheter shaft 202, for example as illustrated in FIG. 2B. In some cases, in the second state, the plurality of first electrodes 208 are deactivated (e.g., by electrically disconnecting the first electrodes 208 from any pulse generator circuitry) and the plurality of second electrodes 210 are activated and used to generate a local ablation lesion by electroporation.

The ablation catheter 200 has a longitudinal axis 222. As used herein, a longitudinal axis refers to a line passing through the center of gravity of a cross-section of an object. In an embodiment, the plurality of splines 204 form a cavity 224. The plurality of splines 204 form a cavity 224a in a first state and a cavity 224b in a second state. In an embodiment, the volume of the cavity 224a is greater than the volume of the cavity 224b. In some embodiments, in the first state, the maximum cross-sectional area of the cavity 224a generally perpendicular to the longitudinal axis 222 has a diameter d1. In some embodiments, in the second state, the maximum cross-sectional area of the cavity 224b generally perpendicular to the longitudinal axis 222 has a diameter d2. In some cases, the diameter d1 is greater than the diameter d2.

In some examples, diameter d1 ranges from 20 millimeters to 35 millimeters. In certain examples, diameter d1 ranges from 10 millimeters to 25 millimeters. In some examples, diameter d2 ranges from 5 millimeters to 16 millimeters. In some examples, diameter d2 ranges from 5 millimeters to 16 millimeters. In one example, diameter d1 is 30% to 100% larger than diameter d2. In one example, diameter d1 is at least 30% larger than diameter d2. In one example, diameter d1 is at least 20% larger than diameter d2. In one example, diameter d1 is at least 100% larger than diameter d2 (i.e., at least twice as large as diameter d2). In one example, diameter d1 is at least 150% larger than diameter d2 (i.e., at least 2.5 times as large as diameter d2).

In some cases, the first group of electrodes 208 is disposed at or proximate to the periphery of the plurality of splines 204, and the second group of electrodes 210 is disposed proximate to the distal end 212 of the catheter 200. In some cases, the first group of electrodes 208 is referred to as the proximal electrodes, and the second group of electrodes 210 is referred to as the distal electrodes, with the distal electrodes 210 disposed closer to the distal end 212 of the electroporation ablation catheter 200 than the proximal electrodes 208. In some implementations, the electrodes 225 may include a thin film of conductive ink or optical ink. The ink may be polymer-based. The ink may further include materials such as carbon and/or graphite in combination with the conductive material. The electrodes may include biocompatible low-resistance metals such as silver, silver flake, gold, and platinum that are further radiopaque.

Each electrode in the first group of electrodes 208 and each electrode in the second group of electrodes 210 is configured to conduct electricity and be operably connected to a controller (e.g., controller 90 of FIG. 1 ) and an ablation energy generator (e.g., electroporation generator 130 of FIG. 1 ). In an embodiment, one or more of the electrodes in the first group of electrodes 208 and the second group of electrodes 210 include a flex circuit. In some cases, the plurality of first electrodes 208 are individually controllable. In some cases, the plurality of second electrodes are individually controllable. In some cases, all or a portion of the plurality of first electrodes 208 are deactivated in the second state. In some cases, a portion of the plurality of second electrodes 210 are deactivated in the second state.

The electrodes in the first electrode group 208 are spaced apart from the electrodes in the second electrode group 210. The first electrode group 208 includes electrodes 208a-208f, and the second electrode group 210 includes electrodes 210a-210f. Also, the electrodes in the first electrode group 208, such as electrodes 208a-208f, are spaced apart from one another, and the electrodes in the second electrode group 210, such as electrodes 210a-210f, are spaced apart from one another.

The spatial relationship and orientation of the electrodes in the first electrode group 208 and the second electrode group 210 relative to other electrodes on the same catheter 200 are known or can be determined. In an embodiment, the spatial relationship and orientation of the electrodes in the first electrode group 208 and the second electrode group 210 relative to other electrodes on the same catheter 200 are constant once the catheter is deployed.

With respect to the electric field, in an embodiment, each of the electrodes in the first electrode group 208 and each of the electrodes in the second electrode group 210 may be selected to be an anode or a cathode, so that an electric field can be established between any two or more of the electrodes in the first and second electrode groups 208 and 210. Also, in an embodiment, each of the electrodes in the first electrode group 208 and each of the electrodes in the second electrode group 210 may be selected to be biphasic, so that the electrodes switch or alternate between an anode and a cathode. With respect to the electric field, in an embodiment, the groups of electrodes in the first electrode group 208 and the groups of electrodes in the second electrode group 210 may be selected to be an anode or a cathode or a biphasic, so that an electric field can be established between any two or more of the groups of electrodes in the first and second electrode groups 208 and 210.

In embodiments, the electrodes in the first electrode group 208 and the second electrode group 210 may be selected to be biphasic electrodes, such that during a pulse train, including a biphasic pulse train, the selected electrodes switch or alternate between anode and cathode, rather than resulting in a monophasic delivery in which one electrode is always the anode and the other always the cathode. In some cases, the electrodes in the first and second electrode groups 208 and 210 may form an electric field with an electrode(s) of another catheter. In such cases, the electrodes in the first and second electrode groups 208 and 210 may be the anode of the electric field or the cathode of the electric field.

Furthermore, as described herein, the electrodes are selected to be one of an anode and a cathode, but it should be understood without stating that throughout this disclosure, the electrodes may be selected to be biphasic, switching or alternating between an anode and a cathode. In some cases, one or more of the electrodes in the first electrode group 208 are selected to be cathodes and one or more of the electrodes in the second electrode group 210 are selected to be anodes. In an embodiment, one or more of the electrodes in the first electrode group 208 may be selected as cathodes and another one or more of the electrodes in the first electrode group 208 may be selected as anodes. Furthermore, in an embodiment, one or more of the electrodes in the second electrode group 210 may be selected as cathodes and another one or more of the electrodes in the second electrode group 210 may be selected as anodes.

In some cases, the first group of electrodes 208 is positioned proximal to the maximum circumference (d1) of the catheter spline 204, and the second group of electrodes 210 is positioned distal to the maximum circumference of the catheter spline 204. In some embodiments, additional electrodes (i.e., mapping electrodes) may be added to each of the multiple splines 204.

3A-3C are schematic diagrams illustrating an ablation catheter 300 that can be used for electroporation ablation, including ablation by irreversible electroporation, in accordance with an embodiment of the subject matter of the present disclosure.

3A shows a catheter 300A in a first state, referred to as a first mode of operation. In some embodiments, the catheter 300A includes an electrode assembly 301A. The electrode assembly 301A has a first shape, referred to as a basket shape in FIG. 3A. The catheter 300 includes a catheter shaft 302. The electrode assembly includes a plurality of splines 304 coupled to the catheter shaft 302 at a distal end 306 of the catheter shaft 302. The catheter splines 304 include a plurality of electrodes 310 disposed on the catheter splines 204. Each of the electrodes in the plurality of electrodes 310 is configured to conduct electricity and to be operably connected to an electroporation generator (e.g., electroporation generator 130 in FIG. 1). In an embodiment, one of the electrodes in the plurality of electrodes 310 includes a metal.

The electrode assembly 301A has a proximal end 316 near the distal end 306 of the catheter shaft 302 and a distal end 314 further away from the distal end 306 of the catheter shaft 302. As shown, the catheter shaft 302 defines a longitudinal axis 312, and the plurality of splines 304 are arranged in a curved shape between the distal end 314 and the proximal end 160. In an embodiment, each spline 304 of the electrode assembly 301 in the first state is arranged as a curve without a turning point. In some examples, each spline 304 has a curvature less than a predetermined degree. For example, each spline 304 has a curvature less than 45°.

3B shows catheters 300B and 300C in an end view in a second state, referred to as a second mode of operation, and FIG. 3C shows catheter 300C in a side view in the second state. In an embodiment, each of the plurality of splines 304 includes one or more electrodes 310 disposed thereon. For example, as shown, spline 304a includes four electrodes. In some embodiments, each of the plurality of splines 304 may include more than four electrodes. In some embodiments, each of the plurality of splines 304 may include fewer than four electrodes. As can be appreciated by one skilled in the art, the number of electrodes on each spline can be adjusted, including the spacing between each electrode. The catheter shaft may further include a cap 324. In an embodiment, cap 324 is atraumatic to reduce trauma to tissue.

Each of the multiple splines 304 shown has a similar size, shape, and spacing between adjacent electrodes 310 on the spline 304. In other embodiments, the size, shape, and spacing between adjacent electrodes 310 on the spline 304 may differ. In some embodiments, the thickness and length of each of the multiple splines 304 may vary based on the number of electrodes and the spacing between each electrode on the spline 304. The splines 304 may be made from similar but different materials and may vary in thickness or length.

As shown, each of the plurality of splines 304 is disposed in a petal-like curve 322 in a second state in which the distal end 314 of the electrode assembly 301 is adjacent to the proximal end 316 of the electrode assembly 301. Each of the plurality of splines 304 may pass through the distal end 306 of the catheter shaft 302 and be coupled to the catheter shaft 302 within the catheter shaft lumen. The distal end of each of the plurality of splines 304 may be coupled to a cap 324 of the catheter 300. In some embodiments, one or more of the curves 322 are electrically insulated. As shown, the petal-like curve 322 includes a turning point.

In some embodiments, the catheter 300B includes an electrode assembly 301B arranged in a second shape, or a shape referred to as a flower shape, as shown in FIG. 3B. In some embodiments, the catheter 300C includes an electrode assembly 301C arranged in a second shape, as shown in FIG. 3C. As shown, each of the plurality of splines 304 may include a flexible curvature to rotate or twist and bend to form a petal-shaped curve 322. The minimum radius of curvature of the splines in the petal-shaped configuration may be in the range of about 7 mm to about 25 mm. For example, the splines 304 may form the electrode assembly 301 at the distal portion of the catheter 300 and may be configured to transform between a first shape in which the set of splines is arranged generally parallel to the longitudinal axis of the catheter 300 and a second shape in which the set of splines is rotated or twisted around the longitudinal axis of the catheter 300 and generally biased away from the longitudinal axis of the catheter. In the first shape, each spline of the set of splines 304 may lie in one plane with the longitudinal axis 312. In the second shape, each spline of the set of splines 304 may be biased away from the longitudinal axis 312 to form a petal-like curve 322 disposed generally perpendicular to the longitudinal axis 312. In this manner, the set of splines 304 may twist and bend and be biased away from the longitudinal axis 312 of the catheter 300, thus allowing the splines 304 to more easily conform to the geometry of the endocardial space, particularly adjacent the opening of the pulmonary ostium. The second shape may resemble a flower shape from an end view, for example, as shown in FIG. 3B. In some embodiments, each spline in the set of splines in the second configuration may twist and bend to form a petal-like curve that, when viewed from the front, exhibits an angle of curvature between the proximal and distal ends of the curve that approaches 180 degrees.

The set of splines may be further configured to transform from the second shape to a third shape, and the set of splines 304 may be pressed against (e.g., contact) a target tissue, such as tissue surrounding a pulmonary vein ostium. The splines 304 may form a shape generally parallel to the longitudinal axis 312 of the catheter shaft 302 when undeployed, and may be wound (e.g., helically wound, twisted) about an axis (not shown) parallel to the longitudinal axis 312 when fully deployed, forming any intermediate shape (such as a cage or barrel) between the various shapes.

4A-4B are diagrams illustrating an example of a graphical user interface 400 according to an embodiment of the subject matter of the present disclosure. As described above, an electroporation catheter system (e.g., electroporation device 60 of FIG. 1) including a controller (e.g., controller 90 of FIG. 1) generates a graphical representation 403 of an electric field that can be generated using an electroporation catheter based on a model of the electric field and overlays the graphical representation 403 of the electric field on an anatomical map 402 of the patient's heart. This graphical representation may assist a user in planning an ablation by irreversible electroporation and/or provide real-time visual feedback regarding the progress of the ablation for the user to adjust the ablation plan accordingly. In an embodiment, the controller (e.g., controller 90 of FIG. 1) is configured to display these and other graphical representations in the superposition of the graphical representation of the electric field on the anatomical map on a display (e.g., display 92 of FIG. 1).

In some embodiments, the controller (e.g., controller 90 of FIG. 1) is configured to display only a three-dimensional surface with no thickness in the overlay of the graphical representation of the electric field on the anatomical map. In some embodiments (not shown), the graphical representation 403 may include different colors to represent different intensities of the projected electric field. In some embodiments (not shown), the graphical representation 403 may include a gradient or vector field to represent different intensities of the projected electric field.

As shown, a catheter 405 including an electrode assembly 401 is deployed within a vein in a patient's heart. The graphical user interface includes a graphical representation 406 of an electric field having an ablation effect on surrounding tissue on an anatomical map 402 of the patient's vein. An axis 410 is a projection axis of the catheter 405 aligned with the axis of the vein (not shown). In some examples, the graphical representation 406 includes an area 407, where the electric field strength of the electric field within the area 407 is greater than a predetermined threshold. In some examples, the graphical representation 406 includes an area 407, where the electric field strength of the electric field within the area is greater than an electroporation threshold (e.g., 250 V/cm). In one particular example, the graphical representation 406 includes an area 407, where the electric field strength of the electric field within the area is greater than an irreversible electroporation threshold (e.g., 400 V/cm). The graphical user interface 400 includes a representation of the catheter 405, a longitudinal axis 410, an anatomical map 402, and a predicted electric field as a function of the deployed shape of the catheter 405, allowing a user to advance or navigate the catheter 405 during a treatment session without the need for fluoroscopy.

The electrode assembly includes a plurality of splines 404 including one or more electrodes 408 disposed on the splines. The one or more electrodes 408 may include an ablation electrode and/or a mapping electrode. In some examples, the one or more electrodes may be disposed on other components of the catheter 405, such as an end cap at the distal end 416 and the catheter shaft (not shown).

In some embodiments, FIGS. 4A and 4B are updated in real time to show the catheter position and the electric field generated by the catheter 405. In certain embodiments, the graphical representation 406 of the electric field includes one or more indicators including, for example, colors representing electric field strength, tissue contact, and location. In some examples, the graphical representation 406 may be a different color than the color of the previous graphical representation 406 if the catheter 405 has moved from a previous location of a previous treatment session associated with the previous graphical representation to a new location in the current treatment session. In certain examples, the graphical representation 406 may be a different color than the color of the previous graphical representation 406 if the catheter 405 has rotated from a previous treatment session associated with the previous graphical representation. In some examples, the colors are grayscale colors. In certain embodiments, FIGS. 4A and 4B are presented side-by-side to show changes in the treatment session. In some embodiments, the electric field of the catheter 405 is generated based on the known relative locations of the electrodes within the catheter.

FIG. 4A shows the catheter 405 in a first state with the splines 404 arranged in a curve between the proximal end 414 of the electrode assembly 401 and the distal end 416 of the electrode assembly 401 as a first shape (e.g., basket shape). FIG. 4B shows the catheter 405 in a second state with the splines 404 arranged in a petal-like curve as a second shape (e.g., flower shape). In some embodiments, the splines 404 are electrically insulated. When the electrode assembly 401 is in the first shape, the splines on the electrode assembly 401 may be arranged generally parallel to the longitudinal axis of the catheter 405. In the first shape, each spline may be in a plane with the longitudinal axis 410.

In some embodiments, as shown in Figures 4A and 4B, the first shape of the electrode assembly 401 when the catheter 405 is in the first state is dissimilar to the second shape of the electrode assembly 401 when the catheter 405 is in the second state. In other embodiments, as shown in Figures 2A-2B, the volume of the electrode assembly shape in the first state is different from the volume of the spline shape in the second state.

As described above, a controller (e.g., controller 90 of FIG. 1) is configured to control an electroporation generator (e.g., electroporation generator 130 of FIG. 1) to generate electrical pulses and deliver therapy to a target area within a cardiac chamber of a patient. In some embodiments, the controller may be configured to generate a first graphical representation of the electric field of the plurality of electrodes in a first state based on a first model of the electric field, generate a second graphical representation of the electric field of the plurality of electrodes in a second state based on a second model of the electric field, and overlay the first and second graphical representations of the electric field on an anatomical map of the patient at the target location where the catheter 405 is deployed.

When the electrode assembly 401 is in the second configuration, the splines on the electrode assembly 401 rotate or twist around the longitudinal axis of the catheter 405, generally biasing away from the longitudinal axis of the catheter 405. In the second configuration, each spline may be biased away from the longitudinal axis 410 to form a petal-like curve disposed generally perpendicular to the longitudinal axis 410. In this manner, the set of splines 304 twist and bend away from the longitudinal axis 410, thus allowing the splines to more easily conform to the geometry of the endocardial space, particularly adjacent the opening of the pulmonary ostium. The second configuration may resemble the shape of a flower from an end view, for example, as shown in FIG. 4B. In some embodiments, each spline in the set of splines in the second configuration may twist and bend to form a petal-like curve that, when viewed from the front, exhibits an angle of curvature between the proximal and distal ends of the curve that approaches 180 degrees.

4A and 4B, the set of splines may be further configured to change from a second shape to a third shape, and the splines may press against (e.g., contact) a target tissue, such as tissue surrounding a pulmonary vein ostium. The splines may form a shape generally parallel to the longitudinal axis 410 when undeployed, and may be wrapped (e.g., helically wrapped or twisted) about an axis (not shown) parallel to the longitudinal axis 410 when fully deployed, forming any intermediate shape (such as a cage or barrel) between the various shapes.

5A-5C illustrate a software widget 500 that facilitates planning and/or performing an ablation treatment, according to certain embodiments of the present disclosure. In an implementation, the software widget 500 is implemented by a set of software instructions executed by one or more processors. As shown, the numbers 502, 504 represent the number of ablation treatment sessions (e.g., session 1, session 2). 502 indicates a previous treatment session, and 504 indicates a current treatment session that the user is performing. In some examples, the multiple squares 506, 508 located outside the circle 515 represent the location of the electrodes of the catheter in a cross-sectional view. In one particular example, the multiple squares 506, 508 located outside the circle represent the location of the splines on the electrode assembly as viewed from a cross-sectional view. 506 represents the location of the splines during a first (past) session, and 508 represents the location of the splines during a second (current) session. In some examples, as shown, the catheter is rotated 25 degrees between the first and second sessions. In other examples not shown, the rotation angle may be greater or less than 25 degrees.

In an embodiment, the catheter representation 510 indicates the relative position of the electrode assembly between each session. As shown in FIG. 5A, the catheter representation 510 with multiple teeth 511 located inside a circle 515 indicates that the electrode assembly is in a more distal position along the patient's vein compared to the previous application/session. As shown in FIG. 5B, the solid circle 5155 indicates that the position of the electrode assembly remains substantially the same within the patient's vein compared to the previous application/session. As shown in FIG. 5C, the dashed circle 515 indicates that the position of the electrode assembly is in a more antral or proximal position along the patient's vein or heart chamber compared to the previous application/session.

In an embodiment, the software widget 500 includes an alignment indicator 512. In some examples, as shown in FIGS. 5A and 5C, the alignment indicator 512 is an arrow or dashed arrow indicating a misalignment of the projected axis of the catheter (e.g., an axis defined by the catheter shaft of the catheter) relative to the axis of the target ablation area in the patient's vein or heart chamber. The alignment indicator 512 may have various shapes and/or colors. As shown in FIG. 5B, the alignment indicator 512 is a dot indicating that the projected axis of the catheter shaft is substantially aligned with the axis of the target ablation area in the patient's vein or heart chamber.

In some embodiments, the controller (e.g., controller 90 of FIG. 1) may be configured to generate and display software widget 500 including a representation of a catheter and an indication of one or more treatment sessions of electroporation ablation (not shown in FIGS. 5A-5C). In embodiments, the software widget includes an indication identifying a treatment session of the one or more treatment sessions. In some embodiments, the software widget includes a cross-sectional view of the catheter (e.g., catheter 105 of FIG. 1). The controller may be further configured to generate a graphical representation of the electric field of the multiple electrodes based on a model of the electric field and display the graphical representation of the electric field of the multiple electrodes.

In embodiments, the software widget 500 includes an alignment indicator 512 representing an axial relationship between the catheter and a target ablation area of the electroporation ablation treatment. In some examples, the representation of the catheter 105 includes a first representation of the catheter at a first time and a second representation of the catheter at a second time. The first representation and the second representation may indicate a difference between the catheter at the first time and the catheter at the second time. The indicated difference includes at least one of a difference in shape, a difference in rotation angle, and a difference in location. In some embodiments, the software widget further includes an electric field display representing the electric field.

6A-6B are diagrams illustrating graphical representations of software widgets and electric fields displayed side-by-side, according to embodiments of the disclosed subject matter.
As shown, a catheter 600 including an electrode assembly 601 is deployed within a patient's heart chamber. A display (e.g., display 92 of FIG. 1 ) shows a graphical representation 606 of the electric field having an ablation effect on the surrounding tissue on an anatomical map 602 of the patient's heart chamber. Axis 610 is the projected axis of catheter 600 that is aligned with the axis of the targeted ablation area (not shown).

The electrode assembly includes a plurality of splines 604 and one or more electrodes 608 disposed on each of the plurality of splines 604. The one or more electrodes 608 may include ablation electrodes and/or mapping electrodes. Each of the plurality of splines 604 may include additional electrodes other than the one or more electrodes 608.

FIG. 6A shows the catheter 600 in a first state in which the splines 604 are arranged in a basket shape between the distal end 614 of the electrode assembly 601 and the proximal end 616 of the electrode assembly 601. FIG. 6B shows the catheter 600 in a second state in which the splines 604 are arranged in a flower shape with pedal-like loops. In some embodiments, the loops are electrically insulated.

In some embodiments, as shown, the curve shape in the first state does not resemble the loop shape in the second state. In other embodiments, as shown above in Figures 2A-2B, the shape of the spline in the first state simply differs from the shape of the spline in the second state.

As described above, a controller (e.g., controller 90 of FIG. 1) is configured to control an electroporation generator (e.g., electroporation generator 130 of FIG. 1) to generate electrical pulses and deliver therapy to a target area within a patient's vein. In some embodiments, the controller may be configured to generate a first graphical representation of the electric field of the plurality of electrodes in a first state based on a first model of the electric field, generate a second graphical representation of the electric field of the plurality of electrodes in a second state based on a second model of the electric field, and overlay the first and second graphical representations of the electric field on an anatomical map of the patient at the location of the catheter.

In some embodiments, the controller (e.g., controller 90 of FIG. 1) may be configured to generate and display a software widget 618 including a representation of the catheter 600 and an indication of one or more treatment sessions of electroporation ablation (not shown). The software widget 618 may include any embodiment and configuration as described herein. In an embodiment, the software widget includes an indication identifying a treatment session of the one or more treatment sessions. In some embodiments, the software widget includes a cross-sectional view of the catheter 600 as indicated by the line 620 in FIG. 6A. The controller may be further configured to generate a graphical representation of the electric field of the multiple electrodes based on a model of the electric field and display the graphical representation of the electric field of the multiple electrodes.

In embodiments, the software widget 618 includes an alignment indicator representing an axial relationship between the catheter and a target ablation area of the electroporation ablation treatment. In some examples, the representation of the catheter 105 includes a first representation of the catheter at a first time and a second representation of the catheter at a second time. The first representation and the second representation may indicate a difference between the catheter at the first time and the catheter at the second time. The indicated difference includes at least one of a difference in shape, a difference in rotation angle, and a difference in location. In some embodiments, the software widget further includes an electric field display representing the electric field (not shown).

Figures 7A-7B show examples of electric fields with various strengths generated by a catheter including an electrode assembly. As shown, the catheter 700 includes a catheter shaft 702 and an electrode assembly 701. The electrode assembly includes a plurality of splines 704 coupled to a distal end 706 of the shaft 702. Each of the plurality of splines 704 includes one or more electrodes 708. The catheter shaft 702 defines a longitudinal axis 712 extending along the length of the shaft 702.

FIG. 7A shows the catheter 700 in a first state in which a plurality of splines 704 are arranged in a curved configuration between the distal end 714 and the proximal end 716 of the electrode assembly 701. As shown, the proximal end 716 of the electrode assembly 701 extends from the catheter shaft 702 of the flexible catheter 700.

FIG. 7B shows the catheter 700 in a second state in which the splines 704 are arranged in a petal-like curve between the distal end 714 and the proximal end 716 of the electrode assembly 701. As shown, the distal end 714 is further away from the proximal end 716 of the electrode assembly 701 in the first state compared to the second state. Thus, the depth of the electric field generated in the first state (L1) is greater than the depth of the electric field generated in the second state (L2). Similarly, the width of the electric field generated in the first state (W1) is less than the width of the electric field generated in the second state (W2).

The inner electric field 718 is located closer to the electrode assembly 701 and is relatively stronger than the outer electric field 720, which is located further away from the electrode assembly 701. In some examples, the inner electric field 718 may be about 400 volts/centimeter or greater. In some cases, the outer electric field 720 may be about 250 volts/centimeter or greater, but less than 400 volts/centimeter. In some embodiments, the inner electric field 718 may be strong enough to perform irreversible electroporation. In some embodiments, the outer electric field 720 may only be strong enough to perform reversible electroporation.

8 is a flow chart diagram illustrating a method for planning ablation by irreversible electroporation, according to an embodiment of the presently disclosed subject matter. The method is described in connection with a catheter previously described herein, however, any suitable electroporation catheter may be used in the method. Aspects of the method embodiments may be performed, for example, by an electrophysiology system or controller (e.g., system 50 of FIG. 1, controller 90 of FIG. 1). One or more steps of the method are optional and/or may be modified by one or more steps of other embodiments described herein. In addition, one or more steps of other embodiments described herein may be added to the method.

At 800, the method includes determining a location of an electrode in the patient relative to cardiac tissue after the catheter is inserted into the patient, and at 802, the method includes determining a characteristic of cardiac tissue near or surrounding the catheter in the patient.

At 804, the method includes modeling an electric field that may be generated by the catheter in one of a plurality of states. Also, in some embodiments, the method includes selecting an electrode that is most likely to be suitable for ablating the target cardiac tissue by electroporation, including ablation of the target superficial tissue and deeper tissue. In embodiments, this includes providing user input, such as a voltage amplitude. In embodiments, the method includes modeling an electric field that may be generated by an electrode assembly of the catheter with different shapes. In some examples, the electrode assembly of the catheter has a shape in a first state that is different from the shape in a second state. In embodiments, the electrodes of the catheter have known relative positions when the catheter is in various states.

In some embodiments, at 804, the method includes generating, by the controller, a first graphical representation of a first electric field generated using electrodes on the catheter in a first state based on a first model of the electric field, the catheter including an electrode assembly having a first shape when the catheter is in the first state. In some embodiments, at 804, the method includes generating, by the controller, a second graphical representation of a second electric field generated using electrodes on the catheter in a second state based on a second model of the electric field, the catheter including an electrode assembly having a second shape when the catheter is in the second state, the second shape being different from the first shape. In some examples, the second shape is dissimilar to the first shape.

In some embodiments, the method further includes generating an indication of the difference between the first graphical representation of the first electric field and the second graphical representation of the second electric field.
At 806, the method includes estimating the electric field shape at a particular electric field strength, including, for example, the surface area and depth of the cardiac tissue that is or can be affected by the electric field. In an embodiment, the method includes determining the strength of the electric field at different portions of the cardiac tissue. In some examples, the electric field is determined with some uncertainty. In an embodiment, this includes determining an electric pulse for generating an electric field between selected electrodes to ablate tissue by irreversible electroporation. In an embodiment, this includes determining an electric pulse for generating an electric field between selected electrodes to ablate tissue by irreversible electroporation based at least in part on the known relative locations of the electrodes. Also, in an embodiment, this includes determining administration parameters for the electric field, such as the electric field strength and the length of time the electric field is applied to the cardiac tissue.

At 808, the method includes generating, by the controller 90, a graphical representation of an electric field that may be generated using selected electrodes on the catheter based on a model of the electric field. In an embodiment, the method includes generating the graphical representation of the electric field based on characteristics of the catheter, a position or location of the catheter within the patient, and characteristics of cardiac tissue surrounding the catheter within the patient.

At 810, the method includes displaying a graphical representation of the electric field and an anatomical map of the patient on a display, such as display 92, which may be used to assist in planning electroporation ablation and/or to modify the ablation plan in real time according to the displayed representation. In an embodiment, this includes overlaying a graphical representation of the electric field of interest on an anatomical map of the heart. In an embodiment, displaying the graphical representation includes displaying an electric field strength based on an electric pulse parameter of an electric pulse provided to selected ones of the electrodes.

In some embodiments, at 810, the method includes presenting, on a display, a first graphical representation of the electric field and an anatomical map of the patient proximate the target location. In some embodiments, at 810, the method includes presenting, on a display, a second graphical representation of the electric field and an anatomical map proximate the target location.

In an embodiment, the graphical representation may include displaying one or more of the following: electric field lines in a graphical representation of the electric field on an anatomical map, an electric field strength threshold line in a graphical representation of the electric field on an anatomical map, markings where the electric field strength threshold line crosses surrounding tissue, displaying a predicted zone of reversible electroporation, displaying a predicted zone of irreversible electroporation, displaying markings where the electric field crosses a previously created lesion, and displaying the predicted lesion on the anatomical map.

At 812, the method includes generating and displaying a software widget (e.g., software widget 500 of FIGS. 5A-5C) to facilitate ablation planning. In an embodiment, the software widget includes representations of one or more of the catheter, catheter location, catheter rotation angle, treatment session progress, catheter alignment, and other relevant ablation information.

In some embodiments, the method may further include generating a software widget that includes a second representation of the catheter and a display of one or more treatment sessions of electroporation ablation performed by the catheter. In some embodiments, the method may further include presenting the software widget on a display.

The method returns to 800 for the next treatment session. In an embodiment, the method also includes dynamically changing, by the controller, the graphical representation of the electric field over the treatment session based on one or more of changes in the position of the catheter relative to the surrounding tissue, changes in the catheter, changes in pulse parameters provided to the electrodes of the catheter, and changes in the measured impedance values of the surrounding tissue.

Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the above-described embodiments refer to certain features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof.

Claims (15)

a catheter including an electrode assembly and a plurality of states, the electrode assembly having a first shape when the catheter is in a first of the plurality of states and the electrode assembly having a second shape when the catheter is in a second of the plurality of states, the second shape being different from the first shape, the electrode assembly including a plurality of electrodes;
A controller,
generating a first graphical representation of a first electric field that exceeds an electroporation threshold generated by the plurality of electrodes when the catheter is in the first condition and deployed proximate to a target location based on a first model of the electric field;
generating a second graphical representation of a second electric field that exceeds an electroporation threshold generated by the plurality of electrodes when the catheter is in the second state and deployed proximate to the target location based on a second model of the electric field;
and a controller configured to overlay, in a graphical user interface, the first graphical representation of the first electric field and the second graphical representation of the second electric field onto an anatomical map of the patient proximate to the target location. The system of claim 1, wherein the second shape is dissimilar to the first shape. The system of claim 1 or 2, wherein the volume of the second shape is smaller than the volume of the first shape. The system of any one of claims 1 to 3, wherein the catheter includes a catheter shaft defining a longitudinal axis, the electrode assembly includes a plurality of splines, a proximal end, and a distal end, at least a portion of the plurality of electrodes are disposed on the plurality of splines, and the proximal end of the electrode assembly extends from the catheter shaft. The system of claim 4, wherein each spline of the plurality of splines is curvedly disposed about the longitudinal axis between the distal end and the proximal end of the electrode assembly when the catheter is in the first condition. The system of claim 4, wherein the plurality of splines are arranged in a petal-like curve when the catheter is in the second state. The system of any one of claims 1 to 6, wherein the controller is further configured to generate a display of a difference between the first graphical representation of the first electric field and the second graphical representation of the second electric field. The system of any one of claims 1 to 7, wherein the first graphical representation of the first electric field includes one or more first areas, and a magnitude of an electric field strength of the first electric field in the one or more first areas is greater than a predetermined threshold. The system of claim 8, wherein the second graphical representation of the second electric field includes one or more second areas, and a magnitude of an electric field strength of the second electric field in the one or more second areas is greater than a predetermined threshold. The system of any one of claims 1 to 9, wherein the first graphical representation includes a first representation of the catheter. The controller further comprises:
generating a software widget including a second representation of the catheter and a display of one or more treatment sessions of electroporation ablation performed by the catheter;
configured to present the software widget in the graphical user interface;
The system of any one of claims 1 to 10, wherein the software widget includes an indication identifying a treatment session of the one or more treatment sessions. generating, by a controller, a first graphical representation of a first electric field generated using electrodes on a catheter in a first state based on a first model of the electric field, the catheter including an electrode assembly having a first shape when the catheter is in the first state;
presenting on a display the first graphical representation of the electric field and an anatomical map of the patient proximate a target location;
generating, by a controller, a second graphical representation of a second electric field generated using electrodes on the catheter in a second state based on a second model of the electric field, the catheter including an electrode assembly having a second shape when the catheter is in the second state, the second shape being different from the first shape;
and presenting on the display the second graphical representation of the electric field and the anatomical map proximate to the target location. The method of claim 12, wherein the second shape is dissimilar to the first shape. 14. The method of claim 12 or 13, further comprising generating an indication of the difference between the first graphical representation of the first electric field and the second graphical representation of the second electric field. generating a software widget including a second representation of the catheter and a display of one or more treatment sessions of electroporation ablation performed by the catheter;
The method of any one of claims 12 to 14, further comprising the step of: presenting said software widget on said display.

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